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Other Disclosures4588Oncolys BioPharma Inc.Pharmaceuticals

Notice Regarding Responses to Inquiries

The company responded to questions from shareholders and investors regarding the review status of OBP-301, for which an application for approval was previously submitted, and the treatment effects confirmed in clinical trials. OBP-301 is currently under regulatory review, and the company plans to begin sales in the fiscal year ending December 2026.

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Announced details

OBP-301Pembrolizumab
Applicable field (uses covered by this announcement)

Third-line treatment for adenocarcinoma of the stomach and esophagus

Launch dateFiscal year ending December 2026 (planned)
What the company reported numerically
Quantitative Effects

Clear tumor shrinkage was observed in 3 of 16 patients, 2 of whom survived for more than 5 years. In 1 patient, the primary gastric and esophageal tumors and lymph node metastases disappeared completely.

Usage history

16 patients enrolled in the clinical trial (as of the time of the trial)

Relationship between the counterparty and the company
Oncolys BioPharma Inc.4588
Relationship with the Company

The company underwent PMDA review and a conformity assessment and received a notice of the results. Deliberation by the Pharmaceutical Affairs and Food Sanitation Council under the Ministry of Health, Labour and Welfare is expected. Manish Shah (マニッシュ・シャー) is the principal investigator for this trial. Further details of capital and personnel relationships are Not disclosed.

CounterpartyPharmaceuticals and Medical Devices Agency (PMDA)Ministry of Health, Labour and WelfareCornell University, Manish Shah (マニッシュ・シャー)

PMDA is an incorporated administrative agency responsible for reviewing pharmaceuticals and other products. The Ministry of Health, Labour and Welfare is the government ministry overseeing the Pharmaceutical Affairs and Food Sanitation Council. Manish Shah (マニッシュ・シャー) is the principal investigator for this trial and is affiliated with Cornell University. Further details are Not disclosed.

Impact on Business Performance

The company has indicated plans to begin sales of OBP-301, but the specific amount or percentage of its impact on financial results is Not disclosed.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Clinical trial results reported at IOVC2026 (International Oncolytic Virus Conference)

Announced details
ItemDetails
Names of Products / Services CoveredOBP-301, Pembrolizumab
CounterpartyPharmaceuticals and Medical Devices Agency (PMDA), Ministry of Health, Labour and Welfare, Cornell University, Manish Shah (マニッシュ・シャー)
Counterparty overviewPMDA is an incorporated administrative agency responsible for reviewing pharmaceuticals and other products. The Ministry of Health, Labour and Welfare is the government ministry overseeing the Pharmaceutical Affairs and Food Sanitation Council. Manish Shah (マニッシュ・シャー) is the principal investigator for this trial and is affiliated with Cornell University. Further details are Not disclosed.
Relationship with the CompanyThe company underwent PMDA review and a conformity assessment and received a notice of the results. Deliberation by the Pharmaceutical Affairs and Food Sanitation Council under the Ministry of Health, Labour and Welfare is expected. Manish Shah (マニッシュ・シャー) is the principal investigator for this trial. Further details of capital and personnel relationships are Not disclosed.
Launch dateFiscal year ending December 2026 (planned)
Applicable areaThird-line treatment for adenocarcinoma of the stomach and esophagus
Quantitative EffectsClear tumor shrinkage was observed in 3 of 16 patients, 2 of whom survived for more than 5 years. In 1 patient, the primary gastric and esophageal tumors and lymph node metastases disappeared completely.
Usage history16 patients enrolled in the clinical trial (as of the time of the trial)
Impact on Business PerformanceThe company has indicated plans to begin sales of OBP-301, but the specific amount or percentage of its impact on financial results is Not disclosed.
SourceClinical trial results reported at IOVC2026 (International Oncolytic Virus Conference)
Items this document does not state (8)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scale

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Selected questions received from shareholders, investors and other stakeholders were answered to ensure fair disclosure of information.

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Notice Regarding Responses to Inquiries | Oncolys BioPharma Inc. (4588) timely disclosure | Komori